Overview
A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
To examine the continued safety and tolerability of four doses of vesnarinone in HIV-infected patients who have completed a short-term study (less than 12 months on continuous treatment) of the drug.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Otsuka America PharmaceuticalTreatments:
Vesnarinone
Criteria
Inclusion CriteriaConcurrent Medication:
Allowed:
- Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
- Acyclovir for acute treatment of herpes.
Exclusion Criteria
Concurrent Medication:
Excluded:
- Antiretroviral agents, including ddI, ddC, AZT, and d4T.
- Immunosuppressive agents.
- Investigational HIV drugs/therapies including vaccines.
- Interferon or other immunomodulating agents.
- Corticosteroids (other than topical).
- Megestrol acetate.
- Agents known to cause neutropenia.
- Ganciclovir.
- Cytotoxic chemotherapy.
Concurrent Treatment:
Excluded:
- Radiation therapy.
Patients with the following prior conditions are excluded:
- Poor compliance (less than 80 percent of drug taken) on the Phase I protocol (FDA 234A
or FDA 234B).
- Missed more than one clinic visit on the Phase I protocol.
Prior Medication:
Excluded:
- Acyclovir as prophylaxis for herpes within 48 hours prior to study entry.
Patients meet the following criteria:
Successful completion of short-term therapy with vesnarinone on FDA 234A or FDA 234B.
Active illicit drug abuse.